[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Notices]
[Pages 14394-14395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Survey of IRB Chairs 
Concerning the Implementation of Pediatric Research Regulations

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Clinical Center, the National Institutes of 
Health (NIH) has submitted to the Office of Management and Budget (OMB) 
a request to review and approve the information collection listed 
below. This proposed information collection was previously published in 
the Federal Register on October 17, 2000, page 61341 and allowed 60 
days for public comment. No public comments were received. The purpose 
of this notice is to allow an additional 30 days for public comment. 
The National Institutes of Health may not conduct or sponsor, and the 
respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    Proposed Collection: Title: Survey of IRB Chairs Concerning the 
Implementation of Pediatric Research Regulations. Type of information 
Collection Request: New. Need for Use of Information Collection: In 
order to assess the protection of children who are enrolled in clinical 
research, it is important to determine how Institutional Review Boards 
(IRBs) reviewing such research interpret and implement the Federal 
Regulations for research with children set forth in 45 CFR 45 subpart 
D. This study aims to gather this information through telephone 
interviews with chairpersons of IRBs that review clinical research with 
children. In addition, we will solicit background information on each 
IRB from the IRB chair. In particular, the survey aims to assess how 
IRBs assess risk/benefit levels of research with children, when IRBs 
permit children's assent to be waived, what information IRBs require 
children to be presented during the assent process, and which children 
are excluded from participation in riskier research. In addition, the 
survey will attempt to determine how the recent NIH Policy and 
Guidelines on the Inclusion of Children as Participants in Research 
Involving Human Subjects has affected IRB review. Frequency of 
Response: Once. Affected Public: Individuals. Type of Respondents: IRB 
chairpersons. The annual reporting burden follows in the table below. 
The annualized cost to respondents is estimated at: $10,000. There are 
no Capital Costs to report. There are no Operating or Maintenance Costs 
to report.

[[Page 14395]]



                                   Respondent and Burden Estimate Information
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                                                                     Estimated                       Estimated
                                                     Estimated       number of        Average      total annual
               Type of respondents                   number of     responses per   burden hours    burden hours
                                                    respondents     respondent     per response      requested
----------------------------------------------------------------------------------------------------------------
IRB chairs......................................             400               1             0.5             200
                                                 ---------------------------------------------------------------
    Total.......................................             400  ..............  ..............             200
----------------------------------------------------------------------------------------------------------------

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies are invited on one or more of the 
following points: (1) Whether the proposed collection of information is 
necessary for the proper performance of the function of the agency, 
including whether the information will have practical utility; (2) the 
accuracy of the agency's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) ways to minimize 
the burden of the collection of information on those who are to 
respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. To request more information on 
the proposed project or to obtain a copy of the data collection plans 
and instruments, contact: Dave Wendler, Ph.D., Head, Unit on Vulnerable 
Populations, Department of Clinical Bioethics, NIH, Building 10, Room 
1C118, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free 
number (301) 435-8726 or fax or e-mail your request, including your 
address, to: Facsimile number (301) 496-0760 and email address 
[email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received on or before 
April 11, 2001.

    Dated: March 2, 2001.
David K. Henderson,
Deputy Director, Warren G. Magnuson Clinical Center, National 
Institutes of Health.
[FR Doc. 01-6010 Filed 3-9-01; 8:45 am]
BILLING CODE 4140-01-M